UIMC
Chicago, Illinois, 60612, United States
NCT Number: NCT00592202
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
Looking for future studies?
Notify Me14 year–17 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
Time frame: Every six months
Time frame: every six months
Time frame: every six months
University of Illinois at Chicago
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07639502
Body Weight, Morbid Obesity
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06199635
Body Weight, Morbid Obesity
Santiago, Huechuraba, Región Metropolitana, Chile
View Trial DetailsNCT06268990
Body Weight, Diabetes
Graz, Austria
View Trial DetailsNCT07662538
Body Weight, Digestive System Diseases
Istanbul, Turkey (Türkiye)
View Trial Details